Transcript TISSUE DONATION THE LIFE ENHANCING OPTION

Elaine R. Berg
President & CEO
WHAT WE WILL COVER TODAY:
1. National picture: Supply vs. Demand
2. How the donation & allocation
system works
3. Regulatory oversight of the donation & allocation
system
4. “Where do donors come from?”
THE NEED
THE ESSENTIAL ISSUE
Need for Organ Donation in U.S.
91,532 as
of 4-7-06
91,532
100,000
84,333 88,149
90,000
79,226 80,666
76,005
80,000
69,550
65,005
70,000
56,716
60,000
50,130
50,000
28,112
40,000
25,451 27,035
24,861
30,000
22,854 24,076
21,941
20,898
20,961
20,494
20,000
7,593
10,000
6,811 7,151
0 5,419 5,479 5,791 5,843 5,984 6,081 6,184
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Deceased Donors
Transplants
Size of Waiting Lists
THE NEED
• More
than 93,000 men, women & children
currently await life-saving transplants
• The
need for organs is expected to
increase in the coming years
(Hep C, aging population …)
• Every
13 minutes another name is added
to the national transplant waiting list
• 17
people die each day on average from
the lack of available organs for
transplant – That’s 6,000 each year
THE NEED IN THE UNITED STATES
66,116
Kidney
Liver
17,257
Heart
3,008
Lung
3,090
Kidney/Pancreas
2,507
Pancreas
1,751
Heart / Lung
150
Intestine
193
Total Persons
Waiting:
93,000
Source: UNOS, April 3, 2006
Data subject to change due to future data submission or correction.
DONOR AVAILABILITY
•
•
•
•
Only 1.5% of all people who die in hospitals are
eligible to be organ donors
In the NYODN region, there are approximately
56,000 hospital deaths per year
Only 650 of those are eligible to be donors
Only 300 families consent to donation
RESPONSES
TO THE
SHORTAGE
DECEASED & LIVING DONORS
1996 – 2005
8,000
7,004
6,811
6,609
7,000
6,000
6,109
5,984
5,801 5,849
5,000
3,000
3,757 4,022
7,150 6,097
6,445 6,184 6,455
5,700
5,418 5,477
4,000
7,593
4,475 4,712
2,000
1,000
1996
1997
1998
1999
Deceased Donors
2000
2001
2002
Living Donors
2003
2004
2005
DECEASED & LIVING ORGAN DONORS
NEW YORK STATE, 1992 – 2005
700
601
600
511
500
362
400
300
267
200
100
161
309
201
329
536
344
327
2000
2002
522
541
353
398
424
2003
2004
2005
342
244
0
1992
1994
1996
1998
Deceased Donors
Living Donors
Source: UNOS/OPTN
DONATION AFTER CARDIAC DEATH
600
556
500
389
400
300
264
200
100
62
82
112
165
190
0
1998 1999 2000 2001 2002 2003 2004 2005
OPTN data from UNOS
THE OUTCOMES
OF
TRANSPLANTATION
ONE-YEAR, FIVE-YEAR GRAFT SURVIVAL
100
Percent Graft Survival
90
80
Kidney C
Kidney L
K-P (P)
Liver C
Heart
Lung
70
60
50
40
30
20
10
0
1 YEAR
5 YEAR
From US OPTN 2003 Annual Report
TRANSPLANT TIMELINE
1668 First successful bone graft (dog to man –
repair cranium)
1868 First skin graft
(by Swiss surgeon Jacques Louis
Reverdin)
1906 First corneal transplant
1954 First kidney transplant
(brother to brother,
performed by Dr. Murray at
Peter Bent Brigham Hospital in Boston)
1963 First liver transplant (by Dr. Starzl in Denver)
1964 First lung transplant (by Dr. James Hardy, Univ. of
Mississippi in Jackson, MS)
1964 First heart transplant (by Dr. Christian Barnard,
Groote Schur Hospital,
Cape Town, South Africa)
1968 First pancreas transplant
(by Dr. Lillche, Univ. of
Minnesota, Minneapolis)
TRANSPLANT TIMELINE, cont.
1968 First definition of brain death based on
neurological criteria
1969 First legislative proposal addressing organ
donation, the Uniform Anatomical Gift Act
(UAGA); Established legal mechanism to
donate organs
1978 Introduction of Cyclosporin as a major
immunosuppressant
1978
Kidney transplants included under Medicare
coverage
1979
NCCUSL recommends Uniform Determination
of Death Act for adoption by all 50 states
TRANSPLANT TIMELINE, cont.
1980 Presidential Commission establishes neurologic criteria for
determination of death, expanding on Harvard Criteria.
1984 National Organ Transplant Act
► Prohibited
buying & selling of organs
► Established
OPTN & Scientific Registry
1980’s Living-Related liver transplants
1987 UAGA – Legal & uniform framework for organ donation;
amends 1969 version
1990’s Living-Related lung transplants
1998
Routine Referral Legislation
2000 HHS implemented a Final Rule establishing a regulatory
framework for the structure & operations of the OPTN.
Under the terms of the Final Rule, policies intended to be
binding upon OPTN members are developed through the
OPTN committees & Board of Directors & then submitted to
the Secretary of HHS for final approval.
FEDERAL
OVERSIGHT
U.S. DONATION / TRANSPLANT
SYSTEM OVERSIGHT
Department Of Health and Human Services
CMS
HRSA
FDA
Licensure
Reimbursement
Policy/Regulation
Compliance
Policy/Regulation
Compliance
U.S. DONATION / TRANSPLANT
SYSTEM MANAGEMENT
Department of Health and Human Services
Health Resources Services Administration
Office of Special Programs
Department of Transplantation
SRTR
OPTN
NMDP
REGULATORY
OVERSIGHT OF
HOSPITALS
REGULATORY OVERSIGHT
OF HOSPITALS

New York State Dept of Health

JCAHO

CMS – 1998 Hospital Conditions
of Participation
CMS - HOSPITALS
CONDITIONS OF PARTICIPATION
Effective: August 1998
Enforcement: August 1999

Hospitals required to notify OPO of
ALL deaths AND IMMINENT DEATHS
in a timely manner

Maintain patient viability to evaluate
for brain death
 Request
for organ / tissue donation will
be made only by trained requestors
HOW THE
SYSTEM WORKS
NATIONAL ORGAN TRANSPLANT ACT
of 1984 (NOTA)
 Single nationwide network (OPTN)
 Private & non-profit under Federal
contract (UNOS)
 Transplant Centers & OPO’s must be
members of OPTN to receive
Medicare reimbursement
 OPO’s required to be non-profit
OPTN CONFIGURATION
• Transplant Centers – 254
• OPO’s – 58
• Histocompatibility Labs – 152
• Voluntary Health Organizations – 8
• Professional /Scientific Organizations – 27
• Consortium Members – 3
• General Public Members – 12
OPTN RESPONSIBILITIES
 Organ match & placement
 Policies / procedures for recovery, distribution &







transportation
Collect / manage scientific data
Provide data to stakeholders
Professional / public education
Created by National Organ Transplantation Act
of 1984 (NOTA)
Management of waiting list
Oversight of transplant centers
Oversight of OPO’s (currently 58 in U.S.)
(range from 1 million population to 16 million)
ORGAN PROCUREMENT ORGANIZATION SERVICE AREAS
1. New England Organ Bank
2. LifeChoice Donor Services
3. NJ Organ and Tissue Sharing Network
4. Center for Donation and Transplant
5. Upstate NY Transplant Services
6. NY Organ Donor Network
7. Finger Lakes Donor Recovery Network
8. LifeLink of Puerto Rico
9. Center for Organ Recovery and Education
10. Washington Regional Transplant Consortium
11. Transplant Resource Center of Maryland
12. Gift of Life Donor Program
13. Nevada Donor Network
14. LifeNet
15. Alabama Organ Center
16. LifeQuest Organ Recovery Services
17. LifeShare of the Carolinas
18. Mississippi Organ Recovery Agency
19. TransLife
20. LifeLink of Florida
21. LifeCenter Northwest Donor Network
41. Arkansas Regional Organ Recovery Agency
22. Carolina Donor Services
42. Louisiana Organ Procurement Agency
23. Pacific Northwest Transplant Bank
43. New Mexico Donor Services
24. Life Alliance Organ Recovery Agency
44. LifeShare Transplant Donor Services of OK
25. Organ Donor Center of Hawaii
45. Southwest Transplant Alliance
26. Mid-South Transplant Foundation
46. Texas Organ Sharing Alliance
27. LifeLink of Georgia
47. LifeGift Organ Donation Center
28. Kentucky Organ Donor Affiliates
48. Iowa Donor Network
29. Tennessee Donor Services
49. Mid-America Transplant Services
30. LifePoint
50. Midwest Transplant Network
31. Gift of Hope Organ and Tissue Donor Network
51. Nebraska Organ Recovery System
32. Indiana Organ Procurement Organization
52. Donor Alliance
33. Gift of Life Michigan
53. Intermountain Donor Services
34. LifeSource, Upper Midwest OPO
54. Donor Network of Arizona
35. LifeCenter Organ Donor Network
55. OneLegacy
36. LifeBanc
56. Golden State Donor Services
37. Lifeline of Ohio
57. Lifesharing Community Organ & Tissue Donation
38. Life Connection of Ohio
58. California Transplant Donor Network
39. University of Wisconsin Hospital & Clinics OPO
40. Wisconsin Donor Network
THE MATCHING PROCESS
HOSPITAL
TRANSPLANT
CENTER
OPO
DONOR
UNOS
UNOS
( MATCH )
OPO
OPO
( MATCH )
TRANSPLANT
CENTER
RECIPIENT
ORGAN MATCHING CRITERIA
 Medical urgency
 Tissue match
 Blood type
 Waiting time on list (for kidneys)
 Organ size
 Immune status
 Geographic distance
 Done by national computer list at UNOS
HOW LONG CAN AN ORGAN REMAIN
VIABLE ONCE RECOVERED?
Heart
4 hours
Liver
12 - 18 hours
Lungs
4 hours
Pancreas
8 - 12 hours
Kidneys
24 - 48 hours
Intestines
8 hours
HOW OPO’S MAKE DONATION HAPPEN
• Handle all organ & tissue donor referrals
• Donor evaluation, donor management
• Family counseling, consent process
• Surgical recovery of organs & tissues
• Matching of organs to recipients
• Transportation of organs to transplant centers
• Hospital development & professional education
• Public education
• Donor family aftercare
• Public policy
• Data entry, management & dissemination
BARRIERS TO
DONATION
PSYCHOSOCIAL BARRIERS
 Acceptance of personal mortality
 Acceptance of brain death /
confusion with “coma”
 Distrust in the medical community /
poor experience with hospital
 Death & burial rituals
 Skepticism about fair allocation /
where are these organs going?
 Lack of knowledge
MYTHS, MISCONCEPTIONS, &
THE MEDIA
 “They’ll take out my organs before
I’m dead.”
 “It’s impossible to have a regular
funeral service following organ
donation.”
 “Only famous people get
transplanted.”
 “Organ donation costs money.”
“DONATION IS
AGAINST MY
RELIGION”
POTENTIAL DONOR IS NO LONGER
A YOUNG MALE MVA DEATH!
IN THE NYODN REGION:
 Trauma patients are only 22% of organ
donors (39% nationally)
 54% of donors are over 50 (35% nationally)
 21 % of donors are over 65 (10% nationally)
DONATION HELPS DONOR FAMILIES!
Studies show that:
1. 85 – 98% of families who consented
to donation felt it had a positive
impact during their time of grief
2. All respondents had no regrets
regarding their decision to donate
Batten HL, Prottas JM. Kind strangers: The families of organ donors. Health Aff 1987: 37: 35-47.
Bartucci MR. Organ Donation: A study of the donor family perspective.
J Neurosci Nurs 1987: 19(6): 305-309.
Savaria DT, Rovelli MA, Schweizer RT. Donor family surveys provide useful information for
organ procurement. Transplant Proc 1990: 22(2): 316-317.
ORGANS & TISSUES THAT
CAN BE TRANSPLANTED
Heart & Heart Valves
Liver
Intestines
Corneas
Lungs
Kidneys
Pancreas
Femoral Veins
Saphenous Veins
Skin
Bone
Tendons
38
A WORD ABOUT
TISSUE
TISSUES RECOVERED
(CARDIAC DEATH)

Eyes

Skin

Bone

Vascular
USES FOR TISSUE
 Heart Valve Replacement
 Orthopedics: Spine, Joint
 Dental: Bone Replacement
 Corneal Transplant
 Skin for Burns
RESPONSES
TO THE SHORTAGE
• Living donation
• Expanded donor pools
• Donation after cardiac death
• State & National registries
• HRSA Breakthrough
Collaborative
PUBLIC POLICY QUESTIONS
• Presumed consent
• Non-financial incentives
(preferred
status, points for donors, etc.)
• Internet matching
• Organ markets / payment for organs
• Specific registries (Lifesharers…)
• Public solicitation
HOW TO BECOME A DONOR
• SIGN
your driver’s license
(some states require witness)
• SIGN your HOD donation card
• ENROLL in the New York State
Donor Registry
• TALK
to your family about end of
life decisions, including donation
FINAL THOUGHTS
 More than 93,000 men, women & children currently
await life-saving transplants
 Every 13 minutes another name is added to the
national transplant waiting list
 17 people die each day on average from the lack
of available organs for transplant
 In 2004, there were 7,150 deceased organ donors &
7,004 living organ donors, resulting in 27,035 organ
transplants
 Over 46,000 cornea transplants were performed in
2003
 Over 900,000 tissue transplants were performed in
2003
SOURCES: COALITION ON DONATION
http://www.shareyourlife.org/facts_stats.html
FINAL THOUGHTS
THE GIFT OF LIFE
Donating a loved one’s organs can
give solace to a family experiencing
the grief & pain of a sudden & tragic
loss.
Transplantation is not a stopgap.
Recipients live full & useful lives for
decades after transplant.